Product code BZQ
- Device name
- Monitor, Breathing Frequency
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.2375
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | 2025-09-26 |
| K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | 2025-08-05 |
| K243183 | RTMsense Respiratory Monitoring System | Rtm Vital Signs, LLC | 2025-06-27 |
| K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. | 2025-04-09 |
| K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | 2025-04-04 |
| K233953 | Makani Science™ Respiration Monitoring System | Makani Science, Inc. | 2025-03-28 |
| K242798 | Airmod | Heroic Faith International , Ltd. | 2025-02-28 |
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | 2024-09-11 |
| K223681 | Respiree Cardio-Respiratory Monitor | Respiree Pte, Ltd. | 2023-03-08 |
| K221555 | Dozee VS | Turtle Shell Technologies Private Limited | 2022-12-15 |
| K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | Baxter Healthcare Corproration | 2022-11-18 |
| K220111 | RespiraSense | Pmd Solutions | 2022-10-07 |
| K211387 | Breathe Easy Mobile Respiratory Monitor (MRM) | Sound Life Sciences, Inc. | 2021-11-23 |
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation | Hill-Rom, Inc. | 2021-03-04 |
| K200445 | The C100 Contactless Breathing Monitor | Circadia Technologies, Ltd. | 2020-06-24 |
| K190734 | Linshom Respiratory Monitoring Device (LRMD) | Linshom Management, LLC | 2020-01-30 |
| K190775 | The RHEA Vital Sign Vigilance System | Shenzhen Fiber Medical Technology Co. , Ltd. | 2019-12-19 |
| K173976 | Masimo Acoustic Respiration Sensors, infant and neonate | Masimo Corporation | 2018-09-05 |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation | Hill-Rom, Inc. | 2018-05-07 |
| K171836 | EarlySense Bed Sensing Unit | Earlysense, Ltd. | 2018-01-04 |
| K152911 | EarlySense Insight Sytem | Earlysense, Ltd. | 2016-05-06 |
| K151940 | Thora-3Di, Model T-01 | Pneumacare Limited | 2016-03-10 |
| K133661 | CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM | Earlysense, Ltd. | 2014-06-13 |
| K132320 | INTELLIVUE CL RESPIRATION POD | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014-03-26 |
| K130570 | NEUROVISION MEDICAL MOTION SENSOR | Neurovision Medical Products, Inc. | 2013-12-26 |
| K131379 | EARLYSENSE | Earlysense, Ltd. | 2013-12-18 |
| K122223 | NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO | Philips Medizin Systeme Boeblingen GmbH | 2013-04-12 |
| K120465 | EARLYSENSE (EVERON) SYSTEM | Earlysense, Ltd. | 2012-06-08 |
| K111933 | COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 | Covidien | 2012-03-15 |
| K103631 | SLEEPMINDER BREATHING FREQUENCY INDICATOR | Biancamed Limited | 2011-07-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10889483225295 | MVAP Comfort Sleep Nasal Cannula | SALTER LABS | 2026-03-13 |
| 10889483224366 | MVAP Comfort Sleep Nasal Cannula | SALTER LABS | 2026-03-13 |
| 07640121881053 | 103583 LuMon™ Contact Gel Kit | SenTec AG | 2025-09-08 |
| G2331000000 | SansaTM | Huxley Medical, Inc. | 2024-10-21 |
| G2331000010 | SansaTM | Huxley Medical, Inc. | 2024-10-21 |
| G2331000020 | SansaTM | Huxley Medical, Inc. | 2024-10-21 |
| 10843997006184 | Radius VSM | MASIMO CORPORATION | 2024-08-19 |
| 08720256776529 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024-06-19 |
| 09351356000031 | Stethee Pro Mobile Android Application | M3DICINE PTY LTD | 2020-12-23 |
| 09351356000048 | Stethee Pro Mobile iOS Application | M3DICINE PTY LTD | 2020-12-23 |
| 09351356000055 | Stethee Pro Central Web Application | M3DICINE PTY LTD | 2020-12-23 |
| 10843997013113 | RAS-45 | MASIMO CORPORATION | 2020-09-03 |
| 10653405000792 | CONMED | Conmed Corporation | 2020-04-28 |
| 10653405000808 | CONMED | Conmed Corporation | 2020-04-28 |
| 10884521103382 | Nellcor | Covidien LP | 2017-08-03 |
| 10607411500098 | N/A | SALTER LABS | 2016-09-24 |
| 10607411301022 | BiNAPS | SALTER LABS | 2016-09-24 |
| 10653405064213 | NA | Conmed Corporation | 2016-09-24 |
| 10816843021327 | MicroSnore™ | ROCHESTER ELECTRO-MEDICAL, INC. | 2016-09-24 |
| 10816843021341 | MultiFlow™ | ROCHESTER ELECTRO-MEDICAL, INC. | 2016-09-24 |
| 10816843021365 | Rochester | ROCHESTER ELECTRO-MEDICAL, INC. | 2016-09-24 |
| 10816843021389 | MultiFlow™ | ROCHESTER ELECTRO-MEDICAL, INC. | 2016-09-24 |
| 10816843021402 | UltraFlow™ | ROCHESTER ELECTRO-MEDICAL, INC. | 2016-09-24 |
| 10816843021426 | UltraFlow™ | ROCHESTER ELECTRO-MEDICAL, INC. | 2016-09-24 |
| 10816843021440 | UltraFlow™ | ROCHESTER ELECTRO-MEDICAL, INC. | 2016-09-24 |
| 10607411000307 | ThermiSense | SALTER LABS | 2016-09-24 |
| 07613365000467 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000498 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000481 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000474 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |